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The PixoTest Blood Glucose Monitoring System is comprised of PixoTest Glucose Test Strip, PixoTest Uni-Clip, and the PixoHealth App as the display component of the system. The PixoTest Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. The PixoTest Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended for single person use only and should not be shared. It is not in the diagnosis of or screening for diabetes and is not intended for use on neonates.

PixoTest BGMS consists of the following devices:

• PixoTest Glucose Test Strip (single-use) abbreviated as Glucose Test Strip 1)
• PixoTest Control Solutions (2 levels 1 and 2) optional 2)
• 3. PixoTest Standard Card
• PixoTest Uni-Clip 4)
• ર) PixoHealth App
• Requires compatible smartphone (iPhone 5/5S/6/6S) not provided by iXensor 6)

iXensor provides the following kits:

• Starter (5 Pcs) Kit- includes PixoTest Standard Card, PixoTest Uni-Clip, and 5 Pcs 1) Glucose Test Strip
• 2. 10 Pcs Kit - includes PixoTest Standard Card and 10 Pcs PixoTest Glucose Test Strip

The PixoTest BGMS uses glucose oxidase test methodology to measure capillary whole blood glucose levels from 40 to 500 mg/dL. The system will display "Hi" when the results are above 500 mg/dL and "Lo" when the results are below 40mg/dL.

The provided text describes the performance evaluation of the PixoTest Blood Glucose Monitoring System (BGMS). Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the PixoTest BGMS meets "accuracy specifications" and "usability and risk assessment specifications" as acceptance criteria, but it does not explicitly define the numerical acceptance criteria in the provided text. It states that the study results "demonstrate that the accuracy specifications of PixoTest BGMS meet the acceptance criteria" and "the usability (via questionnaire), user accuracy, and risk assessment specifications of PixoTest BGMS meet the acceptance criteria."

Therefore, a table showing specific numerical acceptance criteria and corresponding performance metrics cannot be fully constructed from the provided text.

2. Sample Size Used for the Test Set and Data Provenance

• System Accuracy Studies (Both iPhone 5/5S and iPhone 6/6S):

  • Sample Size: 100 different subjects for each study.
  • Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The phrase "evaluations conducted on subjects" implies prospective data collection from human participants. No country of origin is mentioned.

• Usability/User Performance Studies (Both iPhone 5/5S and iPhone 6/6S):

  • Sample Size: 105 subject first-time users for each study.
  • Data Provenance: Not explicitly stated, but implies prospective data collection from human participants. No country of origin is mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study involving human readers is mentioned. The studies focus on the device's performance compared to a laboratory reference (YSI 2300 Analyzer) and user performance of the device itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation of the algorithm and device was a primary focus. The "System Accuracy" studies compare the device's measurements directly against a laboratory reference instrument (YSI 2300 Analyzer), which represents the "algorithm only" performance (how accurately the device measures glucose). The PixoTest BGMS is essentially a standalone measurement device with a connected app for display.

7. The Type of Ground Truth Used

• System Accuracy Studies: The ground truth for the system accuracy studies was established by comparing the PixoTest BGMS measurements to values obtained from a YSI 2300 Analyzer lab instrument. The YSI 2300 Analyzer is a common laboratory reference method for glucose measurement, hence, this represents a reference standard/laboratory gold standard.

• Usability/User Performance Studies: The ground truth for user accuracy in these studies would likely be based on whether the results obtained by lay users were within acceptable ranges compared to a reference measurement (though not explicitly detailed for this specific aspect, it's implied by "User Accuracy lay users can obtain accurate results"). Usability itself was assessed via a questionnaire, which is a subjective rather than objective ground truth, but standard for usability assessments.

8. The Sample Size for the Training Set

The document does not provide information about a training set for the device's development or any machine learning models. The studies described are validation studies for the device itself.

9. How the Ground Truth for the Training Set Was Established

Since no training set information is provided, this question cannot be answered from the given text. It's important to note that for a blood glucose monitor system, the "training" aspect would typically be during the calibration and development of the system's chemical and optical components, rather than a machine learning training set in the conventional sense. The "ground truth" during development would involve extensive testing against reference methods.

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